Regulatory Affairs Director - Policy & CommunicationsPosted: November 15, 2009
Position Summary The Regulatory Affairs Policy and Communication Director serves as the primary individual for regulatory intelligence for all Bausch & Lomb pharmaceutical products globally. Understands and leads critical regulatory strategic thinking of Bausch & Lombs role in shaping the external environment. Serves as the primary regulatory liaison for Pharmaceuticals with health authorities. Specific Job Duties ? Serve as a leadership team member for Bausch & Lomb Pharmaceutical Regulatory Affairs function ? Monitor the domestic and international regulatory landscape, including governmental and non-governmental regulations, practices, and guidance ? Understand industry leading practices and the competitive environment ? Navigate strategic issues for Bausch & Lomb pharmaceutical products ? Interpret, and communicate global regulatory intelligence findings (i.e., FDA guidance, OIG actions, EMEA directives, congressional proceedings, etc) that affect Bausch & Lombs pharmaceutical business ? Interpret Regulatory Authority policies and guidance and provide counsel and training as appropriate to Regulatory Affairs personnel and the business ? Build external eminence with regulatory agencies and trade associations by developing strategic relationships that positively affect Bausch & Lomb interests ? Act as primary liaison with global Regulatory Authorities ? Support the development of a Global Regulatory policy for proactive management of receiving and disseminating critical regulatory information ? Coordinate and share information with global counterparts and other business divisions Technical Competencies ? Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations ? Knowledge of current and emerging issues and trends of the pharmaceutical regulatory environment ? Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business ? Ability to influence external regulatory stakeholders and shape the external regulatory environment ? Ability to translate highly complex global regulatory requirements to assist the pharmaceutical organization to strategically manage regulatory risk and operationalize compliance ? Ability to influence and partner within regulatory and with cross-functional teams in a global pharmaceutical organization ? Ability to distill complex information and communicate effectively to the business Professional Competencies ? Demonstrated ability in analytical reasoning and critical thinking skills ? Strong ability to lead and support a collaborative team environment ? Ability to assess project risks and where appropriate, recommend contingency plans and strategies to mitigate risks ? Strong ability to influence and lead in a high matrix global organization ? Strong business acumen and ability to see the business drivers outside of Regulatory Affairs ? Excellent communication skills; both oral and written ? Strong interpersonal skills at the executive level with the ability to influence others in a positive and effective manner ? Demonstrated ability to contribute to a continuous learning and process improvement environment ? Risk adverse where needed with the ability to identify potential solutions to complex problems Please refer to job code 750385 when responding to this ad.
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